Specialist Quality Operations

Summary

• Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
  
  

About The Role

Major accountabilities:

• Coordination and management of analytical method transfers and stability studies. Compilation of data reports
• Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
• Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc
• SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
• Validate spreadsheets
• Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
• Author, approve and archive Impurity risk assessments – Nitrosamines, residual solvents, etc
• Trend and report all QMS elements as per the request
• Monitor, trend and report Health Safety and Environmental parameters
• Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).
• Perform activities of a Quality Control expert as defined by the respective sites
• Support regulatory requirements – routine queries, Chromatogram requests
• Compile Quality performance management decks
• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed
  
  

Key Performance Indicators

• On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects
  
  

Minimum Requirements

• Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
• Min 6 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
• GxP knowledge, Basic IT knowledge
• Good communication, presentation and interpersonal skills
• Experience of working closely with the global stakeholders
  
  

Skills

• Continuous Learning.
• Dealing With Ambiguity.
• Gmp Procedures.
• Qa (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.
  
  

Languages

• Fluent in English (written and spoken)
  
  

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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